Training and Qualification Procedure - ISO 13485

Training and Qualification Procedure - ISO 13485

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ISO 13485:2016 Training & Qualification Procedure Template (QMS.6.2.0-QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Training & Qualification Procedure Template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards. Easy
  • Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain an effective training and qualification procedure, demonstrating robust quality management as required by ISO 13485:2016.

What is the Training & Qualification Procedure?

The Training & Qualification Procedure helps your organization identify, plan, document, and control training processes. This ensures employees are appropriately qualified for their job functions. This procedure applies to anyone at your company who performs work, including full-time employees, fixed assignment employees, part-time employees, or contractors.

How Will This Procedure Help My Company Comply with ISO 13485?

ISO 13485 requires organizations to: Determine the necessary competence for personnel performing work affecting product quality. Provide training or take other actions to achieve or maintain the necessary competence. Our template aids your organization in meeting these requirements and provides supporting evidence for other parts of the standard.

How Else Will the Procedure Benefit My Organization?

Ensure Competency: Provide evidence that your employees are well-qualified for their positions. Standardize Onboarding: Standardize the process through which new employees are inducted and ensure they are well-equipped and capable of carrying out their duties.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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